Congress hits home stretch renewing FDA user fee programs

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Congress hits home stretch renewing FDA user fee programs
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The FDA could begin sending furlough notices to staff if lawmakers don't settle on a mechanism for reviewing prescription drugs, medical devices, generic drugs and biosimilars.

Committee who passed more sweeping versions of the bill with bipartisan support in June.

"The crowded agenda and shrinking number of legislative days presents a real risk that extraneous provisions will be left out," Cowen analysts Eric Assaraf and Rick Weissenstein wrote in a note to clients, in reference to oversight of diagnostics, supplements and cosmetics.Among the issues in play is the FDA's process for regulating lab-developed tests, which are critical to the COVID-19 and monkeypox responses.

Lawmakers like Sen. Rand Paul are seeking to animal testing mandates and allow drug sponsors to use alternative methods where they are suitable. The senator, who's retiring at the end of this year, was out last week recovering from hip surgery but is expected to return this week.

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